Events

Retiro De Equipo (Recall) de Brilliance CT Systems and Gemini & Precedence Systems utilising Brilliance CT Brilliance CT (6, 10, 16, 16P, 40, 64 and Big Bore), Brilliance iCT, Brilliance iCT SP

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2013-RN-00555-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-31
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00555-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    The stated tolerance in the instructions for use manual for the recorded scanner output (ctdivol) that is used to approximate patient dose does not accurately represent all systems. on some systems, the measured ctdivol value may fall outside of these stated tolerances. in a worst case scenario, there is the potential for the delivered dose to exceed the reported dose by an amount almost equivalent of a rescan.
  • Acción
    Philips is providing their customers with additional information that clarifies published specifications and correlation of CTDIvol value measurement.

Device

Brilliance CT Systems and Gemini & Precedence Systems utilising Brilliance CT Brilliance CT (6, 1...
  • Modelo / Serial
    Brilliance CT Systems and Gemini & Precedence Systems utilising Brilliance CT Brilliance CT (6, 10, 16, 16P, 40, 64 and Big Bore), Brilliance iCT, Brilliance iCT SPMultiple product codes affectedARTG Number: 98868Gemini Dual, Gemini 16 Power, Gemini GXL, Gemini LXL, Gemini TF 16, Gemini TF Base/Ready, Gemini TF 64, Gemini TF Big Bore Multiple product codes affectedARTG Number: 118077Precedence SPECT/CTMultiple product codes affectedARTG Number: 117440
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DHTGA